Soybean oil, oligomerized

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - May 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Read-across to a well described study, although not GLP, performed according to OECD 203 (1984), with the single deviation of no analytical measurements. This deviation does not invalidate the study.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

(No analytical confirmation of concentrations of test compound in test solutions)

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

no

Details on sampling:

Not applicable

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solutions were prepared by mechanical dissolving (Ultra-Turrax) of the test substance in the required volume of deionised water. This stock solution was transferred into the test medium of one glass tank 2 hours before the start of the test (i.e. the addition of the fish, t=0 h). In the meantime, until the fish were transferred, the contents of each glass tank were mixed thoroughly using a mechanical stirrer in order to facilitate the dissolving and/or dispersing of the test sample.
- Eluate: not relevant
- Differential loading: not relevant
- Controls: controls were untreated
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not relevant
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)):not relevant
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The following was reported: "In the preparation of the different test batches …. It could be observed that charging the test medium with the test substance led to a flocky dispersion slowly settling up in the course of the test period.”

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Source: West Aquarium GmbH, D-3422 Bad Lauterberg, Germany
- Age at study initiation: about 2 months
- Length at study initiation: Average total length: 2.0 ± 1.0 cm
- Weight at study initiation (mean and range, SD): no data
- Method of breeding: no data
- Feeding during test: 24 hours before the test was started, feeding of the fish was stopped

ACCLIMATION
- Acclimation period: 2 weeks
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Tetra Min Hauptfutter
- Feeding frequency: Twice daily
- Health during acclimation (any mortality observed): no mortality observed

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Not applicable

Hardness:

Not measured during study

Test temperature:

Overall range during study: 20.7 - 22.1 ºC

pH:

7.5 (measured during study)

Dissolved oxygen:

Overall range during study: 100% - >86%

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 0; 100 and 1000 mg/L
The nominal concentrations were not verified.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass tank with dimensions: length 300 mm, width 200 mm and height 220 mm
- Type: open
- Aeration: yes
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water was prepared in accordance with OECD 203;
deionised water used for its preparation was taken from the delivery system of the laboratory.
- Alkalinity: 0.8 mmol/L
- Ca/Mg ratio: 4:1
- Intervals of water quality measurement: pH, oxygen and temperature were measured at 0, 1, 24, 48, 72 and 96 hours.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod and light intensity: no data

EFFACT PARAMETERS MEASURED
Mortality and fish behavior were observed at 0, 1, 24, 48, 72 and 96 hours

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Highest testconcentration. Based on slowly settling dispersions, no chemical analysis of test substance concentrations.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Based on approximate solubility limit of test substance in test medium

Details on results:

- Mortality in test mediums: 0%
- Mortality of control: 0%

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not applicable

Sublethal observations / clinical signs:

The reported LC0 was 1000 mg/L. The test solutions were flocky dispersions, which were observed to be slowly settling up in the course of the test period. The actual concentrations were not confirmed by chemical analysis. All tested concentrations were far above the solubility limit of the test material in water, which is <1 mg/L. The solubility limit in reconstituted test medium may be even less than that in water. Due to the fact that the test solutions were slowly settling dispersions far in excess of the solubility limit, the concentrations of which were not analytically determined, there is no information about the actual concentrations to which the test fish were exposed during the study. However, due to the method of preparation of the test solutions (thorough mixing of stock using Ultra-Turrax mixer, addition of stock to test water, followed by 2 hours of thorough mixing using a mechanical stirrer), it is sufficiently certain that the solubility limit of the test substance in the test water was achieved in all test solutions. Since at 1000 mg/L no fish mortality occurred, the conclusion of the study is that the LC50 is in excess of the solubility limit.

 

Validity criteria fulfilled:

yes

Conclusions:

In a fish acute toxicity test in Brachydanio rerio according to OECD 203 the LC0 and LC50 were found to be 1000 and > 1000 mg/l respectively.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

See attached justification

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Highest testconcentration. Based on slowly settling dispersions, no chemical analysis of test substance concentrations.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Based on approximate solubility limit of test substance in test medium

Details on results:

- Mortality in test mediums: 0%
- Mortality of control: 0%

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not applicable

Sublethal observations / clinical signs:

The reported LC0 was 1000 mg/L. The test solutions were flocky dispersions, which were observed to be slowly settling up in the course of the test period. The actual concentrations were not confirmed by chemical analysis. All tested concentrations were far above the solubility limit of the test material in water, which is <1 mg/L. The solubility limit in reconstituted test medium may be even less than that in water. Due to the fact that the test solutions were slowly settling dispersions far in excess of the solubility limit, the concentrations of which were not analytically determined, there is no information about the actual concentrations to which the test fish were exposed during the study. However, due to the method of preparation of the test solutions (thorough mixing of stock using Ultra-Turrax mixer, addition of stock to test water, followed by 2 hours of thorough mixing using a mechanical stirrer), it is sufficiently certain that the solubility limit of the test substance in the test water was achieved in all test solutions. Since at 1000 mg/L no fish mortality occurred, the conclusion of the study is that the LC50 is in excess of the solubility limit.

 

Validity criteria fulfilled:

yes

Conclusions:

In a fish acute toxicity test in Brachydanio rerio according to OECD 203 the LC0 and LC50 were found to be 1000 and > 1000 mg/l respectively.

Description of key information

Read across from Standolized linseed oil:
96h-LC50: > 1000 mg/l (above solubility limit)
96h-LC0: 1000 mg/l

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1 000 mg/L

Additional information

A study (read-across to bodied linseed oil) according to OECD guideline 203 reports a 96h-LC50 of > 1000 mg/l (above the water solubility limit) with standolized linseed oil. This result is read across to standolized soybean oil.